Tapered Screw-Vent® TSVT6H10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024344242), received between Aug 21, 2020 and May 14, 2026 — classified as 7 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO SEVERE BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 25170619 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WERE REMOVED DUE TO LACK OF PRIMARY STABILITY. WHEN PLACING 4.7MM IMPLANT BONE WAS SOFTER THAN EXPECTED AND WAS UNABLE TO ACHIEVE PRIMARY STABILITY. HAD TO SWITCH TO LARGER DIAMETER SWITCHED TO LARGER 6.0 IMPLANT AND ENDED UP WITH A SMALL FRACTURE OF BUCCAL PLATE SO WAS UNABLE TO ACHIEVE STABILITY HERE ALSO. ENDED UP GRAFTING SITE WITH PUROS. WE WILL GET PATIENT BACK FOR NEW IMPLANT PLACEMENT IN 6 MONTHS

  Patient problems: Bone Fracture(s)

  MAUDE report 19250448 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED TO RETRACT THE INITIAL REPORT, MFR REPORT NUMBER 0002023141-2023-02865 AS THIS EVENT HAS ALREADY BEEN SUBMITTED AND IS A DUPLICATE OF MFR REPORT NUMBER 0002023141-2023-02409 THAT WAS SUBMITTED ON AUGUST 31, 2023.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17917383 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CLINICAL PROCEDURE IT WAS NOTICED THAT THE TISSUE AROUND THE IMPLANT WAS NOT HEALING PROPERLY AND PRESENTED INFLAMMATORY TISSUE AND BONE LOSS AROUND THE IMPLANT COLLAR. THE PATIENT HAD DEVELOPED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #30 WITH ASSOCIATED PAIN. THE INFECTION COULD PROGRESS; THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17663499 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PROGRESSIVE BONE LOSS THAT WAS UNABLE TO BE REPAIRED. TOOTH #30.

  Patient problems: Osteolysis

  MAUDE report 15174394 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11753662 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE THAT REQUIRED ANTIBIOTICS. SITE WAS INFLAMED AND PATIENT WAS EXPERIENCING DISCOMFORT. PATIENT TO RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #3.

  Patient problems: Discomfort; Inflammation; Unspecified Infection

  MAUDE report 10436767 ↗